MARBOTIS®

Auricular use.
Shake well before use and squeeze gently to fill the dropper with the veterinary medicinal product.
Apply ten drops into the ear once daily for 7 to 14 days.
After 7 days of treatment, the veterinary surgeon should evaluate the necessity to extend the treatment
another week.
One drop of the preparation contains 71μg marbofloxacin, 237μg clotrimazole and 23.7μg
dexamethasone acetate.
After application, the base of the ear may be massaged briefly and gently to allow the preparation to
penetrate to the lower part of the ear canal.
The external ear canal should be meticulously cleaned and dried before treatment.

Not applicable.

Do not administer to dogs suffering from perforation of the tympanic membrane.
Do not use in cases of hypersensitivity to the active substance, or to any of the excipients.
Do not administer to pregnant or lactating bitches.

None.

Special precautions for safe use in the target species:

Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level. Use of the product should be in accordance with official, national and regional antimicrobial policies.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach. Before treating with the veterinary medicinal product, the integrity of the tympanic membrane must be verified. The external ear canal should be meticulously cleaned and dried before treatment. Quinolone class drugs have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species. The use of the veterinary medicinal product in young animals is not recommended.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
People with known hypersensitivity to marbofloxacin, dexamethasone, clotrimazole should avoid contact with the veterinary medicinal product. This veterinary medicinal product may cause skin and eye irritation. Avoid contact with skin and eyes. In case of accidental contact, wash exposed area thoroughly with water. Wash hands after use. In case of accidental ingestion or if skin and eye symptoms persist seek medical advice immediately and show the package leaflet or the label to the physician.

Dogs:

* Usual adverse reactions associated with corticosteroid drugs such as changes in biochemical and haematological parameters may be observed.

** Prolonged and intensive use of topical corticosteroid preparations is known to trigger local and systemic effects

***Mainly in elderly dogs and mostly of a transient nature

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.